Bioequivalence and Bioavailability Forum

Dear John

A valid point!!

We have seen the impact on one of the BE study (BCS Class-I product)

1. In the first study all volunteers consumed their breakfast in the way they wanted (eat the egg first, then drink the juice, then eat the bread and then again drank juice): Test product values were lower by 40% and T/R was 66, 68, 68 for Cmax, AUC and AUC inf respectively)
   
2. When the same lot was used in another study where food pattern was kept like: All solid meal first→ Juice→ immediate dosing we observed T/R ratio of 96, 100 and 100 for Cmax, AUC and AUC inf respectively)

Now coming to the logic that why the second study was performed and was comfortable→ It was because the test product contained high amount of MCC and the product was not disintegrating in the churned food (USP-III) when tested in vitro with DT of about 45 minutes where as DT for reference was around 10 min. In another dissolution testing, we added some extra water above the churned food we observed the DT of ~12-15 min. But to confirm the same study was repeated and Voila

P.s: Typing from phone, sorry for spelling mistakes.